Instrument calibration

  💊 Handling OOS (Out of Specification) Results in the Pharmaceutical Industry: A Practical Guide Out of Specification (OOS) results are an inevitable challenge in pharmaceutical quality control. Whether during raw material testing, in-process checks, or final product release, encountering a result that falls outside the approved specification limits can raise red flags. However, OOS results don't automatically mean product failure—what matters most is how you investigate and respond . In this blog, we’ll walk through how pharmaceutical companies should properly handle OOS results in compliance with regulatory expectations (like FDA 21 CFR 211 , MHRA , and ICH Q7 ), while maintaining quality integrity. 🔍 What Is an OOS Result? An OOS result is any test result that falls outside of the predefined acceptance criteria or specification range established in the product dossier or quality documents. This can occur in: Raw material testing In-process quality checks Stab...

Pharmaceutical Labs Handling OOS results What’s your SOP when an out-of-specification result is observed during QC? Immediate action: quarantine product and inform QA. Root cause analysis (RCA) is key. Use fishbone diagrams. Always confirm result with repeat test—avoid re-testing blindly. Re-testing must be scientifically justified, not used to invalidate results. We use CAPA (Corrective and Preventive Action) tracking for all OOS.